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GLP Study Director
2 months ago
- Leads all aspects of studies to ensure data accuracy and report quality
- Develop study protocols that meet technical, project and regulatory objectives
- Ensure that all GLP regulations are communicated to study participants and are strictly observed
- Work independently and collaboratively with the GLP Team to execute GLP studies, design experiments and safely complete assigned tasks in a timely manner
- Collaboratively work with the GLP Team to maintain well organized supporting data files suitable for internal and external auditing
- Complete final reports and archive studies per GLP guidelines
- Ensures product availability, quality, sample transfers and tracking
- Prepare batches with appropriate documentation and tracking for GLP studies
- Conduct testing on batches to ensure quality and generate accurate GLP data for EPA submissions. Testing incudes (but not limited to) pH, titrations, density, physical characteristics, etc.
- Review analytical data and prepare final study reports, taking responsibility for accuracy and compliance
- Prepare and coordinate testing and transfer requirements with other functions
Requirements:
- Associate’s or Bachelor's degree in Chemistry or other related Science discipline, or greater than 2 years of college courses in Chemistry or other related Science discipline
- At least 1 year experience working in a laboratory with product formulation and/or analytical lab experience
Desired:
- 5+ years working in a Laboratory
- Good Laboratory Practice (GLP) or Good Manufacturing Process (GMP) experience
- Experience working on EPA regulated products
Minimum:
- Ability to act as Project Manager of GLP Studies
- Excellent written, oral communication
- High attention to detail
- Excellent organizational, prioritization and decision making skills
- Ability to work independently and as part of a team
- Push for results with desire to learn
- Computer skills including Word and Excel
- Self-motivation, adaptability and multi-tasking skills
- Ability to follow SOP’s and accurate record keeping skills